Olopatadine Hydrochloride

Olopatadine Hydrochloride, a H1-receptor antagonist, widely used for Allergic Conjunctivitis.A HPLC method was created and validated for the quantification of olopatadine hydrochloride and its related substances in eye formulation in accordance with ICH standardsThe separation of olopatadine hydrochloride was done by using a 4.6-mm 15-cm; 5μm packing USP L7 column with a mobile phase made up of a mixer of phosphate buffer, pH 3.0: Acetonitrile (72:28) ratio at a flow rate of 1.0 mL/min and injection volume 30μL.A photodiode array detector was used at a wavelength of 299 nm.The validation parameters including specificity, LOD/LOQ, linearity, accuracy, precision, robustness, and solution stability, were verified for performance of the method.The linearity ranges were 0.02-0.40, 0.0004-0.008 and 0.0001-0.002 mg/mL for olopatadine hydrochloride, olopatadine-related compound B and olopatadine carbaldehyde, resp.The % recovery was within the 80-120%.When the column temperature and flow rate were changed, the system suitability resolution was still within the acceptable range.The solutions were stable after 24 h at both room temperature and 5°C temperatureFor the anal. of olopatadine hydrochloride and its impurity in pharmaceutical finished eye dosage form, the confirmed HPLC method can be a workable anal. approach.

The development of analytical methods that adhere to the principles of sustainable green chemistry is essential in the modern scientific arena. This research presents two novel methods for the concurrent quantification of olopatadine (OLO) and mometasone (MOM), targeting sustainable green chemistry principles in their raw materials, dosage forms and combined nasal spray formulations. The first method is a rapid isocratic high-performance liquid chromatography (HPLC) that achieves excellent resolution within 4 min, with retention times of 2.37 ± 0.1 min for OLO and 4.05 ± 0.1 min for MOM. It features optimal sensitivity, with detection limits of 0.13 µg/mL for OLO and 0.03 µg/mL for MOM. It utilizes a cyano column with an isocratic mobile phase of acetonitrile and 0.1 M OPA (50: 50, v/v), making it accessible to standard laboratory equipment. The second method is UV-visible spectrophotometry, which includes first-order derivative measurement (D1) and ratio derivative spectra (RDS) methods. These spectroscopic approaches provide linear response range of 0.2-20.0 µg/mL for OLO and 4.0-40.0 µg/mL for MOM, respectively serving as cost-effective alternatives for labs with limited resources. Validation results show high accuracy (98-102 %) and precision (RSD < 2 %). Green assessments using Eco-Scale indicate scores of 86 for HPLC and 100 for spectrophotometry, while the "blueness" concept via BAGI demonstrates strong sustainability with scores of 87.5 and 90. These methods effectively quantify OLO and MOM in their raw materials, different formulations and combined nasal spray, providing a sustainable and reliable approach for pharmaceutical analysis. This work is the first green assessment for the determination of OLO and MOM in pure drug and in the pharmaceutical formulations using less hazard solvent and simple technique.